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- Tasks: Manage regulatory dossier builds and submissions to health authorities.
- Company: Join a leading global pharmaceutical organisation based in Surrey, UK.
- Benefits: Enjoy a hybrid work model with competitive pay and potential for growth.
- Why this job: Be part of a vital team ensuring patient safety and compliance in healthcare.
- Qualifications: B.S. in Pharmacy, Life Sciences, or related field; advanced English required.
- Other info: 12-month assignment with opportunities to learn and grow in the pharmaceutical industry.
I am looking for a Dossier Manager to join a Global Pharmaceutical organisation based out of Surrey, UK. The Dossier Manager is accountable for operational management for dossier build and/or publish of regional and/or national regulatory dossiers to designated Health Authorities (HA’s). On behalf of Global Regulatory Sciences (GRS), Dossier Managers manage technical aspects, ensuring delivery of X-regional, regional and/or national regulatory dossiers - development, initial application and subsequent lifecycle updates (compliance and maintenance).
Key Requirements:
- Adhere to FDA regulations 21 CFR 312 and 21 CFR 314, coordinate US regulatory compliance submissions which are driven by relevant Event and/or Calendar to ensure the organisation's legal obligation.
- Monitor and verify Suspected Unexpected Serious Adverse Reaction (SUSAR) arising from clinical trial, report to Regulatory Authority within agreed timeline to protect patient’s safety.
- Submit investigator package (FDA 1572 form and CV of the principal investigator) to Regulatory Authority within 30 days to guarantee patient’s safety and right when new investigator added in the clinical trial study.
- Coordinate and notify Regulatory Authority of any Advertising and Promotional Labelling materials on or before its Date of First Use (DOFU) to protect public health by assuring the prescription drug information is truthful, balanced and accurately communicated in accordance with existing regulation and present guidance.
- Communicates important information to healthcare providers & patients by the promotional materials.
Qualifications:
- B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- Associate: Advanced English language required. Sr. Associate / Manager: Advanced to Fluent English language required. Multilingual skills desirable.
- Advanced Microsoft Office Suite skills.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards, including fluency with publishing and Document Management tools.
- Experience with building & publishing a full paper and electronic submission.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
12 Month Hybrid Assignment based out of Walton Oaks, Surrey PAYE - £19.75 p/h Umbrella - £22.13
Dossier Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Dossier Manager
✨Tip Number 1
Familiarise yourself with FDA regulations, especially 21 CFR 312 and 314. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for a Dossier Manager role.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, particularly those involved in regulatory affairs. Attend relevant conferences or webinars to make connections and gain insights into the latest trends and challenges in dossier management.
✨Tip Number 3
Brush up on your technical skills, especially with Microsoft Office Suite and document management tools. Being proficient in these areas will set you apart from other candidates and show that you're ready to hit the ground running.
✨Tip Number 4
Prepare to discuss your experience with building and publishing regulatory submissions during interviews. Be ready to share specific examples of how you've managed compliance and maintained quality standards in previous roles.
We think you need these skills to ace Dossier Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Dossier Manager. Familiarise yourself with the key requirements mentioned in the job description, such as FDA regulations and the importance of compliance submissions.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the job requirements. Emphasise your technical aptitude, familiarity with regulatory processes, and any experience with publishing and document management tools.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your understanding of the role. Mention specific examples from your past experiences that demonstrate your ability to manage regulatory dossiers effectively.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any grammatical errors or typos, and ensure that all information is accurate and clearly presented. A polished application reflects your attention to detail.
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Familiarise yourself with FDA regulations 21 CFR 312 and 21 CFR 314. Being able to discuss these regulations confidently will show your understanding of the compliance landscape and how it impacts the role of a Dossier Manager.
✨Demonstrate Technical Proficiency
Be prepared to discuss your experience with Microsoft Office Suite and any Document Management tools you've used. Highlight specific examples where you successfully built or published regulatory dossiers, as this will showcase your technical aptitude.
✨Showcase Communication Skills
As a Dossier Manager, you'll need to communicate effectively with various stakeholders. Prepare examples of how you've communicated complex information clearly to healthcare providers or patients, as this will demonstrate your ability to convey important messages.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about past experiences where you had to manage unexpected issues, such as SUSAR reporting, and be ready to explain your thought process and actions taken.
